FDA Approves Daytrana® (methylphenidate Transdermal System) CII For The Treatment Of ADHD In Adolescents

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).


"The FDA approval of Daytrana for adolescents now extends this medication option to an additional group of ADHD patients who may benefit from ADHD treatment delivered by a patch," said Mike Yasick, senior vice president of the Shire ADHD business unit. "This approval reinforces Shire's commitment to providing a varied and comprehensive portfolio of medicines to meet the diverse needs of ADHD patients."


The efficacy of Daytrana was demonstrated in a multi-center, 7-week, phase 3b, randomized, double-blind, placebo-controlled study in 217 adolescents aged 13 to 17 diagnosed with ADHD. The primary efficacy measure was the mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score. The Daytrana treatment group demonstrated significant reduction (indicating improvement) in ADHD-RS-IV total score from baseline to endpoint compared with placebo (P